Edge Pharma recalls 1,750mg/500mL Vancomycin HCl IV injection due to lack of sterility assurance. Affected units were sold from December 2021 to January 2022. Consumers should contact Edge Pharma for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific vancomycin injection product because it may not be sterile. This could lead to infections if used in medical treatments. The recall affects patients receiving this medication through IV injections.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. If used in medical procedures, this could cause serious infections or other health complications.
Patients receiving vancomycin injections via IV from healthcare providers using this specific product. Those with medical conditions requiring this medication are at higher risk.
Check for the product name 'Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag' with NDC 05446-1459-01. The product was sold between December 2021 and January 2022.
Reach out to Edge Pharma at 856 Hercules Dr., Colchester, VT 05446 for specific instructions on handling the recalled product.
The recall states there is a lack of assurance of sterility, so it is not safe to use as it could cause infections.
Look for the NDC code 05446-1459-01 on the product label, which was sold between December 2021 and January 2022.
Contact Edge Pharma directly for instructions on how to handle the recalled product.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0427-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0427-2022 from Edge Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
